Ulcerguard may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ulcerguard in the following countries:
International Drug Name Search
Neriproct may be available in the countries listed below.
Diflucortolone 21-valerate (a derivative of Diflucortolone) is reported as an ingredient of Neriproct in the following countries:
Lidocaine is reported as an ingredient of Neriproct in the following countries:
International Drug Name Search
Dermopanten may be available in the countries listed below.
Dexpanthenol is reported as an ingredient of Dermopanten in the following countries:
International Drug Name Search
Rec.INN
R07AB08
0001165-48-6
C20-H21-N-O3
323
Analeptic
4H-1-Benzopyran-4-one, 8-[(dimethylamino)methyl]-7-methoxy-3-methyl-2-phenyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Doxy-Wolff may be available in the countries listed below.
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Doxy-Wolff in the following countries:
Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Doxy-Wolff in the following countries:
International Drug Name Search
Dimenidrinato may be available in the countries listed below.
Dimenidrinato (DCIT) is known as Dimenhydrinate in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Generic Name: ibuprofen (Oral route)
eye-bue-PROE-fen
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Propionic Acid (class)
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .
In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .
This medicine is available both over-the-counter (OTC) and with your doctor's prescription .
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen in children below 6 months of age. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .
| Pregnancy Category | Explanation | |
|---|---|---|
| 1st Trimester | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
| 2nd Trimester | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
| 3rd Trimester | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Advil Pediatric. Please read with care.
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .
When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .
To lessen stomach upset, you may take this medicine with food or milk .
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .
Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .
This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .
Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away .
Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .
Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Advil Pediatric side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Bi-Profénid may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Bi-Profénid in the following countries:
International Drug Name Search
Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto
Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.
Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.
Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.
Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).
Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.
This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.
a history of allergy to antihemophilic factor; or
a history of allergy to products made with human or animal proteins, especially mouse proteins.
Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).
This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.
Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.
Contact your doctor for instructions if you miss a dose of this medication.
There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;
fast heart rate, chest pain, trouble breathing;
feeling light-headed, fainting; or
pain, redness, swelling, or oozing where the medicine was injected.
Other, less serious side effects may be more likely to occur, such as:
unusual taste in your mouth;
cough, runny or stuffy nose;
mild itching;
swelling in your hands, ankles, or feet;
headache or dizziness;
mild nausea, diarrhea, stomach pain;
sweating;
joint pain; or
chills or flushing (warmth or tingly feeling).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.
There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Beechams Flu-Plus Caplets
Each caplet contains Paracetamol 500 mg, Caffeine 25 mg and Phenylephrine Hydrochloride 5 mg.
For full list of excipients, see section 6.1.
Film coated tablet
The product is recommended for the relief of sinus pain and the symptoms of colds and influenza, including fatigue and drowsiness.
Adults, children aged 12 years and over and Elderly
2 caplets up to 4 times a day.
These doses should not be repeated more frequently than every four hours.
Do not take continuously for more than 7 days without medical advice
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Closed angle glaucoma
Known hypersensitivity to paracetamol or any of the other constituents.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Medical advice should be sought before using this product in patients with these conditions:
An enlargement of the prostate gland
Occlusive vascular disease (e.g. Raynaud's phenomenon)
Cardiovascular disease
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Consult your doctor if you are taking warfarin.
Special Label Warnings
Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special Leaflet Warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopromide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.
Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs:
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This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy.
This product should not be used while breast-feeding without medical advice
Caffeine in breast milk may have a stimulating effect on breast-fed infants.
Phenylephrine may be excreted in breast milk.
Patients should be advised not to drive or operate machinery if affected by dizziness.
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Paracetamol
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* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.
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When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
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Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown
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Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms and signs
Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Treatment
No specific antidote is available, but supportive measures may be used.
Phenylephrine
Symptoms and signs
Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.
Paracetamol is a well established analgesic and antipyretic.
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors (predominantly alpha-adrenergic activity) producing nasal decongestion. Caffeine is the most active xanthine derivative in respect of stimulation of the central nervous system, producing a condition of wakefulness and increased mental activity.
Paracetamol is metabolised by the hepatic microsomal enzymes. It is rapidly and completely absorbed from the gastro-intestinal tract. Plasma concentration reaches a peak in half to one hour, the plasma half-life is one to three hours and it is uniformly distributed throughout the body.
Phenylephrine hydrochloride is irregularly absorbed from the gastro-intestinal tract. When injected intramuscularly it takes 10- 1 5 minutes to act and subcutaneous and intramuscular injections are effective for about one hour. Intravenous injections are effective for about 20 minutes.
Caffeine is readily absorbed from the gastro-intestinal tract.
Not applicable.
The caplets also contain: Starch Pregel, Maize Starch, Povidone, Potassium Sorbate, Sodium Laurilsulfate, Sunset Yellow (E 110), Stearic Acid, Talc and Microcrystalline Cellulose.
The film coating consist of: Hypromellose, Polyethylene Glycol 400, Titanium Dioxide, Sunset Yellow Aluminium Lake (E 110) and Quinoline Yellow Lake (E 104).
None.
24 months.
Store below 25°C in a dry place.
The caplets are packed into PVC 250 µm/ aluminium foil 30 µm blisters in outer boxboard cartons, containing 8, 10, 16, 24 and 32 caplets, or PVC 300 µm/ aluminium foil 30 µm blisters in a cardboard/ PVC wallet containing 12 or 14 caplets.
None.
Beecham Group PLC
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
PL 00079/0335
29 July 1996
May 2010.
Delewal may be available in the countries listed below.
Flupentixol is reported as an ingredient of Delewal in the following countries:
Melitracen is reported as an ingredient of Delewal in the following countries:
International Drug Name Search
Minulette may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Minulette in the following countries:
Gestodene is reported as an ingredient of Minulette in the following countries:
International Drug Name Search
Dermovat may be available in the countries listed below.
Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Dermovat in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Carbocaine (mepivacaine systemic) is a member of the drug class local injectable anesthetics and is used to treat Local Anesthesia.
US matches:
Mepivacaine hydrochloride (a derivative of Mepivacaine) is reported as an ingredient of Carbocaine in the following countries:
International Drug Name Search
Generic Name: sumatriptan (Subcutaneous route)
soo-ma-TRIP-tan
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antimigraine
Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1
Sumatriptan injection is used to treat acute migraine attacks and cluster headaches in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).
Many people find that their headaches go away completely after they use sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.
Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.
Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan injection in the pediatric population. Safety and efficacy have not been established.
Use of sumatriptan injection is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Sumavel DosePro. Please read with care.
Do not use this medicine for a migraine or cluster headache that is different from your usual headaches. Instead, check with your doctor.
To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.
Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.
If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours before using another dose. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not use more than two doses in 24 hours.
This medicine is given as a shot under your skin (usually on the abdomen or stomach, thighs, or upper arms). Sumatriptan injection may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
This medicine is available in 3 forms. You may use a single dose vial, prefilled syringe, or a prefilled autoinjector.
After you have finished injecting the medicine, be sure to follow the precautions in the patient directions about safely discarding the empty cartridge and the needle. Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine or cluster headaches are worse, or if they are occurring more often, than before you started receiving this medicine.
Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients using this medicine.
This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use this medicine for a long time might also have a higher risk.
You should not receive this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.
Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when used with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor first before taking any other medicines.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you have chest discomfort, jaw or neck tightness after receiving this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain after using this medicine.
Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Sumavel DosePro Subcutaneous side effects (in more detail)
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